(150 days)
Not Found
No
The description focuses on electrical muscle stimulation and does not mention any AI/ML components or functionalities.
Yes
The device is designed to treat premature ejaculation by delivering electrical stimulation to delay ejaculation, thus serving a therapeutic purpose.
No
The device is designed to manage premature ejaculation by delivering electrical stimulation, not to diagnose a condition.
No
The device description explicitly states that the vPATCH is a physical patch containing electrodes, an electrical circuit board, and batteries, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of premature ejaculation by delivering electrical stimulation to the perineal muscles and nerves. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the human body.
- Device Description: The device is a patch that delivers electrical muscle stimulation. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) which is the hallmark of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is to directly treat a condition through physical stimulation.
N/A
Intended Use / Indications for Use
The vPatch is indicated for management of premature ejaculation in males who ejaculate after intromission. It is designed to increase the time between arousal and ejaculation by delivery of short duration, low-intensity electrical stimulation to the perineal muscles and nerves during intercourse.
Product codes
QRC
Device Description
The vPATCH is a single-use disposable patch designed to manage premature ejaculation. It contains electrodes that deliver electrical muscle stimulation (EMS) to the perineal muscles during intercourse to help the user postpone ejaculation. The patch works by delivering shortduration, low-intensity EMS to the perineal muscles and nerves during intercourse. The stimulation contracts the pelvic floor muscles, which consequently delays rhythmic contractions of ejaculation. This increases the time between arousal and ejaculation.
The vPATCH is comprised of several layers which include the cover, electrical circuit board including batteries, and adhesive electrodes. The skin-contacting materials are hydrogel, polyolefin foam, and thermoplastic elastomer (TPE).
The vPATCH is available in two intensity levels (High and Low).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
perineal muscles and nerves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility:
The following biocompatibility tests were repeated in accordance with FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process" (September 2020) and the applicable recognized standards:
- Cytotoxicity
- Sensitization
- Irritation
Non-Clinical Performance Testing:
The following non-clinical performance tests were performed:
- Shelf-Life testing: To demonstrate the packaging integrity and functionality of the vPATCH is maintained over its claimed shelf-life duration
- Dimensional validation: To demonstrate that critical measurements of the vPATCH are maintained and are consistent during production
- Cover bonding strength: To demonstrate the suitability of the bonding strength of the vPATCH cover
- Liquid ingress protection: To demonstrate the adequate level of protection of the vPATCH against liquid ingress
- Power performance: To demonstrate the satisfactory power performance of the vPATCH device throughout its claimed shelf-life
Usability Testing:
The human factors validation study was combined with a self-selection study and label comprehension study. The combined study was completed using representative users of the vPATCH from three (3) groups (Indicated, Not Indicated, Contraindicated).
The human factors validation study was conducted in a simulated-use format in which intended users performed the tasks that are necessary to use the vPATCH as intended.
Participants had access to the patch itself, the instructions for use (IFU), and any relevant accessories. The results of the study were analyzed to identify root causes of any difficulties or use errors observed during testing. After the validation study concluded, a supplemental study was conducted to gather data to corroborate a minor design change made to further improve usability of the Product.
The vPATCH has been found to be safe and effective for the intended users, uses, and use environments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5026 Non-implanted electrical stimulation device for management of premature ejaculation.
(a)
Identification. A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device.
(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Mechanical performance;
(ii) Electrical stimulation parameters; and
(iii) Battery performance.
(4) Performance testing must support shelf life by demonstrating continued device functionality over the identified shelf life.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Labeling must include:
(i) Specific instructions regarding safe placement and correct use of the device;
(ii) Warning(s) against use by patients with active implanted medical devices; and
(iii) A shelf life.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 1, 2023
Virility Medical, Ltd. % Bosmat Friedman Regulatory Consultant ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, NC 28269
Re: K223595
Trade/Device Name: vPATCH Regulation Number: 21 CFR§ 876.5026 Regulation Name: Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation Regulatory Class: II Product Code: QRC Dated: April 3, 2023 Received: April 3, 2023
Dear Bosmat Friedman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mark J. Antonino -S
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name vPATCH
Indications for Use (Describe)
The vPatch is indicated for management of premature ejaculation in males who ejaculate after intromission. It is designed to increase the time between arousal and ejaculation by delivery of short duration, low-intensity electrical stimulation to the perineal muscles and nerves during intercourse.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY [as required by section 807.92(c)] vPATCH 510(k) Number K223595
5.1. SUBMITTER
Applicant's Name and Address:
Virility Medical, Ltd. 24 Hanagar St. Hod-Hasharon 4527713 Israel Phone: +972 97447780
Primary Contact:
Bosmat Friedman Regulatory Affairs Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: 980-308-1636 bosmat.f(@promedoss.com
5.2. DEVICE
Trade Name: vPATCH
Classification: Name: Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation Product Code: QRC Regulation No: 876.5026 Class: 2 Medical Specialty: Gastroenterology/Urology Review Panel: GastroRenal, ObGyn, General Hospital, and Urology Devices (OHT3) Reproductive, Gynecology and Urology Devices (DHT3B)
PREDICATE DEVICE 5.3.
vPATCH, manufactured by Virility Medical, Ltd., De-Novo granted DEN210012; Product Code: ORC.
This predicate has not been subject to a design-related recall.
4
5.4. -DEVICE DESCRIPTION
The vPATCH is a single-use disposable patch designed to manage premature ejaculation. It contains electrodes that deliver electrical muscle stimulation (EMS) to the perineal muscles during intercourse to help the user postpone ejaculation. The patch works by delivering shortduration, low-intensity EMS to the perineal muscles and nerves during intercourse. The stimulation contracts the pelvic floor muscles, which consequently delays rhythmic contractions of ejaculation. This increases the time between arousal and ejaculation.
The vPATCH is comprised of several layers which include the cover, electrical circuit board including batteries, and adhesive electrodes. The skin-contacting materials are hydrogel, polyolefin foam, and thermoplastic elastomer (TPE).
The vPATCH is available in two intensity levels (High and Low).
5.5. INDICATIONS FOR USE
The vPATCH is indicated for management of premature ejaculation in males who ejaculate after intromission. It is designed to increase the time between arousal and ejaculation by delivery of short duration, low-intensity electrical stimulation to the perineal muscles and nerves during intercourse.
- OTC use
SUBSTANTIAL EQUIVALENCE 5.6.
The subject and predicate devices are both single use patches applied to perinium for the management of premature ejaculation.
| Feature | Subject Device
vPATCH | Predicate Device
vPATCH (DEN210012) | Comparison to Predicate |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reg. Number | 876.5026 | 876.5026 | Same |
| Product Code | QRC | QRC | Same |
| Indication for
Use | The vPATCH indicated for
management of premature
ejaculation in males who ejaculate
after intromission. It is designed to
increase the time between arousal
and ejaculation by delivery of short
duration, low-intensity electrical
stimulation to the perineal muscles
and nerves during intercourse.
- OTC use | The vPATCH indicated for
management of premature
ejaculation in males who ejaculate
after intromission. It is designed to
increase the time between arousal
and ejaculation by delivery of short
duration, low-intensity electrical
stimulation to the perineal muscles
and nerves during intercourse. - Rx use | Same wording of indications
for use; The proposed
vPATCH has OTC indication
vs. Rx indication of the
predicate; HF testing
including labeling
comprehension and self-
selection support the
expanded indication |
| Principle of
Operation | Patch is applied to the perineum prior
to intercourse and switched on to | Patch is applied to the perineum
prior to intercourse and switched on | Same |
The following table provides a comparison with the predicate:
5
| Feature | Subject Device
vPATCH | Predicate Device
vPATCH (DEN210012) | Comparison to Predicate |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | induce stimulation | to induce stimulation | |
| Biocompatibility | The vPATCH underwent
cytotoxicity, sensitization and
irritation testing | The vPATCH underwent
cytotoxicity, sensitization and
irritation testing | Same |
| Single use | Yes | Yes | Same |
| Sterility | Not sterile | Not sterile | Same |
| Packaging
Configuration | Available in two package
configurations for high and low
intensities; each package type
contains 4 patches of the same
intensity. | Available in three package
configurations. The high and low
intensity patches are provided in
packages that include 4 patches with
the same intensity. The new
vPATCH starter kit includes one
low intensity patch and one high
intensity patch to allow the user to
decide which intensity is right for
him. | A new starter kit was
developed to support the OTC
indication and allow the user
to identify the correct
intensity for him. |
| Stimulation
Current | HIGH Intensity: 14.3mA LOW
Intensity: 9.9mA | HIGH Intensity: 14.3mA LOW
Intensity: 9.9mA | Same |
| Maximal
Stimulation
Duration | 15 minutes | 15 minutes | Same |
Any differences in technological characteristics do not raise different questions of safety or effectiveness.
5.7. PERFORMANCE DATA
As a result of some minor device differences, the following pre-clinical tests were repeated/performed:
Biocompatibility:
The following biocompatibility tests were repeated in accordance with FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process" (September 2020) and the applicable recognized standards:
- -Cytotoxicity
- Sensitization -
- Irritation -
Non-Clinical Performance Testing:
The following non-clinical performance tests were performed:
- Shelf-Life testing To demonstrate the packaging integrity and functionality of the -
6
vPATCH is maintained over its claimed shelf-life duration
- Dimensional validation To demonstrate that critical measurements of the vPATCH are maintained and are consistent during production
- Cover bonding strength To demonstrate the suitability of the bonding strength of the vPATCH cover
- Liquid ingress protection To demonstrate the adequate level of protection of the vPATCH against liquid ingress
- Power performance To demonstrate the satisfactory power performance of the vPATCH device throughout its claimed shelf-life
Usability Testing:
The human factors validation study was combined with a self-selection study and label comprehension study. The combined study was completed using representative users of the vPATCH from three (3) groups (Indicated, Not Indicated, Contraindicated).
The human factors validation study was conducted in a simulated-use format in which intended users performed the tasks that are necessary to use the vPATCH as intended.
Participants had access to the patch itself, the instructions for use (IFU), and any relevant accessories. The results of the study were analyzed to identify root causes of any difficulties or use errors observed during testing. After the validation study concluded, a supplemental study was conducted to gather data to corroborate a minor design change made to further improve usability of the Product.
The yPATCH has been found to be safe and effective for the intended users, uses, and use environments.
5.8. CONCLUSION
The main reason for this submission is to expand the current Rx indication of the vPATCH to an OTC indication. In support of this change, the company has conducted a Human Factors study which included label comprehension and self-selection demonstrating that the intended user population are able to correctly identify themselves as intended users as well as correctly use the device without the need for guidance or intervention of a healthcare professional. With respect to technological differences, the minor modifications implemented to the device have been verified via pre-clinical testing supporting our claim that the vPATCH is as safe and effective as its predicate. The company has provided sufficient pre-clinical and usability testing to demonstrate substantial equivalency to the predicate device. Consequently, it is clear that the vPATCH device is as safe and effective as its predicate and the proposed modifications do not raise any new safety and/or effectiveness concerns.